Associate I
2 meses atrás
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
- Main activities
- Process the adverse event reports from any source as per client/sponsor agreed plans
- Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to:
- Data entry of safety data onto adverse event database(s) and tracking systems
- Review of adverse events for completeness, accuracy and appropriateness for expedited reporting
- Write patient narratives & code adverse events accurately using MedDRA, if applicable
- Determine listedness against appropriate label (for Marketed products, if applicable)
- Identifies clinically significant information missing from initial reports and generate queries for its collection, consulting the medical staff if needed
- Ensure case receives appropriate medical review
- Ensure all cases that require expediting reporting to worldwide regulatory agencies or other recipients are prioritized for processing and submission within the regulatory and/or study specific applicable timelines
- Submission of expedited SAE reports to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Labcorp project personnel, if required & as agreed with client during study set-up, within study specified timelines
- Perform processing of Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs) and submission, including but not limited to
- Maintenance of tracking systems
- Set-up and maintenance of project files and central files for documentation
- Assist with the reporting of ESRs & PSRs to clients, Regulatory Authorities, Ethics Committees, investigators and Labcorp project personnel, as required, within study specified timelines
- Support with quality review or peer review of the processed reports
- Assist and/or complete the database reconciliation and the associated activities, as applicable
- Maintain study/project level documentation as per the agreed requirements, as applicable
- Support with training of PSS staff and mentor the team as needed
- Support with input required for monthly status reports, assist in the generation and maintenance of the PSS metrics (if needed)
- Maintain a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance/ procedural documents and directives associated with safety management, reporting and pharmacovigilance
- Assist in the preparation for client meetings and liaise with client contacts, where appropriate
- Assist in Quality issues management and support audit and inspection preparation, as needed
- Ensure compliance of operations with governing regulatory requirements and applicable study/project plans, and take responsibility for quality of data processed
- Assist in the preparation of client meetings and liaise with clients where appropriate
- Any other duties as assigned by management.
- Requirements- Bachelors Degree preferred (but not necessary) to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.-
- Advanced English-
- Previous experience working in CRO / Pharmaceutical industries in the safety / regulatory / pharmacovigilance areasFortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
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